Effective OnabotulinumtoxinA Dose Response Study for Upper Facial Wrinkles
Status
Conditions
Treatments
Details and patient eligibility
About
This research is being done to determine if lower doses of botox than what is currently recommended can give similar results to patients, at lower cost and lower risk to them. Subjects will receive botox in the same areas of the upper face with standard doses on one side of the face. On the other side, double the botox concentration will be administered, free of charge to the participant, in order to see if the difference in concentration creates a difference in wrinkle reduction and participant satisfaction over time.
Sex
Ages
Volunteers
Inclusion criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18-65
- In good general health as evidenced by medical history and exhibiting upper facial wrinkles on physical examination
- Agreement to adhere to Lifestyle Considerations (see section 5.3) as appropriate throughout study duration
Exclusion criteria
- Current use of aminoglycosides, curare like agents, and muscle relaxants
- Pregnancy or lactation
- Known allergic reactions to components of the botox formulation and any of its ingredients
- Treatment with another botox product for the face within 4 months
- Infections/preexisting weakness at the proposed injection sites on physical examination
- History of neuromuscular disorder, pre existing severe cardiovascular disease, compromised respiratory function, severe dysphagia
- Pediatric population, patients older than 65 since the effect of botox in terms of duration and magnitude is highly variable in these age groups.
Trial design
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups
Trial contacts and locations
Loading...
Central trial contact
Nicholas Bastidas, MD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal